N/A
N=37
Biocontainment Device for Aerosol Generating Procedures
Protective Device (Physical Object) · Aerosol Disease · Droplet Spread
Bottom Line
View on ClinicalTrials.gov: NCT04532112 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. — 46; 37 time (seconds)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biocontainment Device For Aerosol Generating Procedures (Biobox) (Device); Control for aerosol generating procedures (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device. |
46; 37 | — |
| PRIMARY Quantifying the Number of AEs or ADEs to Assess Device Safety. |
3; 0 | — |
| SECONDARY Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort. |
3 | — |
| SECONDARY Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device. |
4 | — |
| SECONDARY Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device. |
4 | — |
Summary
The primary goal of this study is to assess use of a biocontainment device for planned airway procedures under general anesthesia. This will serve as a platform for using this device as a novel biocontainment and aerosol evacuation system as part of rapid sequence intubation protocols for COVID-19 patients. We hypothesize that airway procedures with the aerosol biocontainment device will be safe and effective with airway procedure times approaching times for airway procedures without the device.
Eligibility Criteria
Inclusion Criteria
A) User (healthcare worker):
- Anesthesiologist, anesthesia resident, or CRNA at the Hospital of the University of Pennsylvania or PPMC who has signed and dated informed consent.
B) Patient:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- ASA I, II, III
- Undergoing planned procedure involving an airway procedure under general anesthesia
Exclusion Criteria
A) User (healthcare worker):
- Pregnancy due to potential risks from lifting the device.
B) Patient:
- Known history of difficult airway
- Anticipated difficult airway management for any reason
- COVID-19 positive status
- Pregnancy
- Planned prolonged intubation post-surgery or anticipated inability to answer patient questionnaire within 1 week of intubation.
Data sourced from ClinicalTrials.gov (NCT04532112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.